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Anesthetic mask
EUDAMEDClass IIa (EU MDR)
Ref Adult-M(pvc)Ref Adult-SRef PediatricRef Infant(pvc）Ref Adult-XL(pvc)Ref InfantRef Adult-LRef Adult-XLRef Pediatric（pvc）Ref HY-001-3 Adult S PVCRef HY-001-6 Adult XL PVCRef HY-001-4 Adult M PVCRef HY-001-5 Adult L PVC
Identity
- Trade Name
- Anesthetic mask EUDAMEDAnesthesia Mask EUDAMED
- Device Name
- Anesthetic mask EUDAMED
- Model / Reference
- Adult-M(pvc) EUDAMEDAdult-S EUDAMEDPediatric EUDAMEDInfant(pvc） EUDAMEDAdult-XL(pvc) EUDAMEDInfant EUDAMEDAdult-L EUDAMEDAdult-XL EUDAMEDPediatric（pvc） EUDAMEDHY-001-3 Adult S PVC EUDAMEDHY-001-6 Adult XL PVC EUDAMEDHY-001-4 Adult M PVC EUDAMEDHY-001-5 Adult L PVC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950125 EUDAMED06975834950545 EUDAMED06975834950538 EUDAMED06975834950095 EUDAMED06975834950484 EUDAMED06975834950521 EUDAMED06975834950590 EUDAMED06975834950606 EUDAMED06975834950101 EUDAMED06975834950040 EUDAMED06975834950071 EUDAMED06975834950057 EUDAMED06975834950064 EUDAMED
- Basic UDI-DI
- 697583495ANEMT7 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Anaesthesia face mask, single-use
Anesthetic mask by Ningbo Hanyue Medical Technology CO., LTD. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697583495ANEMT7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (13)
- EUDAMED 5d6cd5ac-cbea-4549-b9a0-31622653afc5 61 fields · synced Oct 6, 2026
- EUDAMED 86fb820d-ede5-41fd-9635-3dbf5311ecd8 61 fields · synced May 16, 2026
- EUDAMED dba572f7-b088-4097-9083-4964a7c90282 61 fields · synced May 17, 2026
- EUDAMED 121a3a11-0243-49bf-89c7-5fe9821ead80 61 fields · synced May 17, 2026
- EUDAMED ed88e0b8-1a39-4742-8268-be7fc9f92cc8 61 fields · synced May 17, 2026
- EUDAMED 90464124-70ab-44da-8cc2-2b02d28b6d05 61 fields · synced May 18, 2026
- EUDAMED d36850f6-620e-412b-986f-33b4435db001 61 fields · synced May 18, 2026
- EUDAMED 4206daaf-8867-429f-8220-76ec2ee651e2 61 fields · synced May 19, 2026
- EUDAMED f2d9c5b9-c22b-4743-82a9-527c62c0035f 61 fields · synced May 19, 2026
- EUDAMED b2687f44-24d3-4529-ac90-fb4d1c46d056 61 fields · synced Jul 9, 2026
- EUDAMED 790a5375-3030-443f-928d-6eb6faf90575 61 fields · synced Jul 10, 2026
- EUDAMED 59cc6f20-5efe-4865-a421-f1d2c7fe8ecc 61 fields · synced Jul 25, 2026
- EUDAMED 12610e57-5d06-45a7-b6b3-93adb7c4f471 61 fields · synced Jul 30, 2026